CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report
Premier Guard Sterile Drape For Use with Blair-Port Wand recalled
Covidien is recalling Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X, distributed nationwide in the US. The recall was initiated on 23 Jan 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1408-2017
- FDA event ID
- 76327
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jan 2017
- FDA classified
- 4 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 Jan 2017 | Recall initiated by company | |
| 4 Mar 2017 | Classified by FDA | +40 days |
| 15 Mar 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility compromised due to breach in sterile barrier
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Where it was distributed
Nationwide
Questions about this recall
Is Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X recalled?
Yes. Covidien recalled Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X on 23 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1408-2017.
Why was it recalled?
Sterility compromised due to breach in sterile barrier
Which lots are affected?
Lot Numbers: 1112351 to 1609891
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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